A novel approach for attention deficit and hyperactivity disorder may soon offer a treatment regimen that is more akin to a video game than a drug, but still manages to control symptoms without any side effects.
This ground-breaking software, which originated in the laboratory of Dr. Adam Gazzaley at the University of California, San Francisco, produced data that will be used to seek regulatory approval from the U.S. Food and Drug Administration early in 2018.
"This is a first-of-its-kind trial and I think we're really looking to distinguish this as a digital medicine," Eric Elenko, chief of research and strategy at PureTech Health, told S&P Global Market Intelligence in an interview. "If you look at other products, what they are doing is disease management. … This is actually a digital intervention that has an effect on the brain, five days a week, about 30 minutes a day." A former consultant at McKinsey, Elenko was speaking on the sidelines of Jefferies' London healthcare conference in November.
Project: EVO's AKL-T01 Source: Akili |
While the software, titled Project: EVO, has the look and feel of a high-end video game, the sophisticated proprietary algorithms that underlie it try to reach a very specific part of the brain, the prefrontal cortex, in order to improve how we process cognitive interference. The software was developed by Akili Interactive Labs Inc., a Boston-based company majority owned by PureTech Health plc, which licensed it from Gazzaley. Results from a pivotal pediatric ADHD trial in 348 children ages eight to 12 years showed that AKL-T01 successfully met its primary endpoint of a statistically significant improvement in the Attention Performance Index.
Akili intends to use the Project: Evo software platform to roll out a number of different applications, with AKL-T01 being the initial indication. Other disease areas being targeted with the same video-game approach include cognitive decline in multiple sclerosis patients and high-functioning autism.
Project: EVO's AKL-T01 Source: Akili
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The medical device has been designed to operate across different software device platforms, including smartphones, the iPad and other tablets. "It's actually independent of the hardware device. That's really important for the breadth and big vision of what digital medicine can be," Akili CEO Eddie Martucci said.
Medicine that looks different
ADHD is a brain disorder characterized by inattention or hyperactivity that interferes with normal functioning and development. The U.S. Centers for Disease Control and Prevention estimates that some 5% to 7% of children have ADHD, but notes that there has been a clear upward trend in diagnoses since the first national survey in 1997; in that time, the number of FDA approved treatments for the condition has also increased as more long-acting medicines, such as Shire plc's Adderall XR, have been introduced to the market.
Standard current treatment for ADHD is to prescribe drugs such as amphetamines and methylphenidate, which many children have insufficient response to or tolerability issues with, while some parents opt not to administer pharmaceuticals at all. "AKL-T01 may have wide applicability and is easy to use, plus there is already a large installed base of iPads, hence we believe adoption could in theory be relatively rapid," said Jefferies analyst Peter Welford, who rates the stock a "buy."
Designing such a novel trial, which compared Akili's pioneering software to a similar type of video game that had no underlying algorithms targeting specific pathways in the brain, was a very interactive process with the regulators, the CEO said, adding that payers recognize there is an unmet need for such a medicine.
"The idea is to seek the reimbursement that can be possible with a medical product," said PureTech's Elenko."The way we look at it is, this is medicine. It just looks different."
Clearly, Akili has the potential to disrupt the current standard of care in the ADHD market and has managed to persuade other big pharma companies, too, with shareholders including Amgen Ventures and Merck Ventures BV, as well as a partnership with Pfizer Inc.
Certainly, of the potential rivals in the ADHD space, Shire — maker of the Adderall franchise, Vyvanse and most recently Mydayis — has taken the threat seriously enough to become a shareholder in Akili, even as the Dublin-based drugmaker draws up plans to exit the neuroscience business that was originally its whole focus. Shire will announce the results of a strategic review of its ADHD business by year-end.
"We're quite excited by it. We think it really goes to the point that it's not building an exciting flashy product that's having an effect, it's actually the core technology underneath," Akili CEO Martucci said. "So whereas people are really excited about what digital can do for healthcare, I think the message that we believe this sends is: that's true, but it's this specific digital medicine that has shown benefits that you need to study and validate before bringing it to patients."


